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Review Question - QID 212520

Interventional Studies Clinical Drug Trials 4 phases for clinical trials evaluating new drugs QID: 212520 (M1.OMB.18.1)
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QID 212520 (Type "212520" in App Search)
A research team is studying the effects of a novel drug that was discovered to treat type 2 diabetes. In order to learn more about its effects, they follow patients who are currently taking the drug and determine whether there are adverse effects that exceed anticipated levels and may therefore be drug-related. They discover that the drug causes an excess of sudden cardiac death in 19 patients with renal failure out of 2 million total patients that are followed. Based on these results, an additional warning about this serious adverse effect is added to the investigator brochure for the drug. Which of the following clinical phase studies does this study most likely describe?
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